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AzTrials

Post-traumatic Stress DisorderEASENCT06592677

Early Support After Exposure to Trauma

A study testing Condensed internet-delivered prolonged exposure (CIPE) and Treatment-as-usual (TAU) in people with Post-traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 29 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A significant proportion of people who are exposed to traumatic events suffer from post-traumatic sequelae, such as post-traumatic stress disorder (PTSD). Indicated preventive interventions soon after trauma could be appropriate. Yet, there is limited evidence for the efficacy of such interventions. Read more about this study

Who is it for?
Ages 16 to 99 years
Conditions the study is for
Post-traumatic Stress Disorder
What is being tested?
Condensed internet-delivered prolonged exposure (CIPE) and Treatment-as-usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
360 participants
Where
29 sitesNorway
Study dates
13 Sep 2024to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Receives support from a municipal crisis team
  • Exposure to a traumatic event (as defined by criteria A for the diagnosis of post-traumatic stress disorder (PTSD) in the DSM-5) within the last seven weeks before randomization
  • A total score of 10 or above on the PTSD Symptom Checklist-5 at the time of randomization
  • Age 16 or above
  • Written informed consent
  • Writes and speaks English and/or Norwegian

Who cannot join

  • Severe psychopathology in need of specialized health care (e.g., psychotic symptoms, or high suicide risk) or substance dependence syndrome in need of specialized health care
  • Known or evident severe cognitive impairment
  • Ongoing traumatization, violence, or threats
  • Unstable dose of psychotropic medication two weeks prior to randomization
  • Concurrent therapy elsewhere before randomization

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Harald Bækkelund, PhD contact

+47 90964268

harald.bakkelund@nkvts.no

Marianne S Birkeland, PhD contact

+47 41433496

m.s.birkeland@nkvts.no

29 sites in 1 country

Norway29 sites, 29 recruiting

  • Asker municipality - Psychosocial crisis team

    Asker, Asker, 1384

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Indre Østfold kommune

    Askim, Askim, 1830

    Harald Bækkelund, D.Clin.Psych, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Aurskog-Høland - Psychosocial crisis team

    Bjørkelangen

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Fredrikstad municipality - Psychosocial Crisis team

    Fredrikstad

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Gjøvik municipality - psychosocial crisis team

    Gjøvik

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Halden Municipality - psychosocial crisis team

    Halden

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Hamar Municipality - psychosocial crisis team

    Hamar

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Søndre Land municipality - psychosocial crisis team

    Hov

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Ullensaker municipality - psychosocial crisis team

    Jessheim

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, St Hanshaugen

    Oslo, Oslo, 0170

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Ullern

    Oslo, Oslo, 0377

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Norwegian Center for Violence and Traumatic Stress Studies

    Oslo, Oslo, 0484

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Espen R Lassen, Clinical psych., phd-candidate, +4791007573

    Recruiting

  • Psychosocial crisis team - Oslo, Nordre Aker

    Oslo, Oslo, 0484

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Østensjø

    Oslo, Oslo, 0694

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Vestre Aker

    Oslo, Oslo, 0754

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Grorud

    Oslo, Oslo, 0954

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Alna

    Oslo, Oslo, 1051

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Søndre Nordstrand

    Oslo, Oslo, 1203

    Harald Bækkelund, PhD, +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Bjerke

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Frogner

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, gamle Oslo

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Grünerløkka

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Nordstrand

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Sagene

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial crisis team - Oslo, Stovner

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Psychosocial emergency service - Oslo emergency room

    Oslo

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Ringsaker municipality - Psychosocial crisis team

    Ringsaker

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Gjerdrum - psychosocial crisis team

    Sørum

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

  • Nannestad municipality - psychosocial crisis team

    Teigebyen

    Harald Bækkelund, PhD, clinical psych., +4790964268, harald.bakkelund@nkvts.no

    Recruiting

Other trials in Norway

About this study

A significant proportion of people who are exposed to traumatic events suffer from post-traumatic sequelae, such as post-traumatic stress disorder (PTSD). Indicated preventive interventions soon after trauma could be appropriate. Yet, there is limited evidence for the efficacy of such interventions. Moreover, no evidence-based preventive interventions are readily available for victims in the aftermath of crises and disasters in Norway. Condensed Internet-delivered Prolonged Exposure (CIPE) is a preventive intervention designed for victims with symptoms of PTSD (PTSS) approximately one month after a traumatic event. The treatment is an internet-delivered, therapist assisted intervention, based on principles from Prolonged Exposure. CIPE has proven to be feasible, safe, and effective in previous studies. This study aims to test the effectiveness and cost-effectiveness of CIPE in the context of psychosocial crisis services in Norwegian municipalities.

Hypotheses Effectiveness H1 Participants receiving CIPE + treatment as usual (TAU) will have significantly less PTSS than participants receiving TAU at 6 weeks post T1, and at 6-, and 12- months after the traumatic incident.

Read more

H2 Significantly fewer participants receiving CIPE+TAU will fulfill the criteria for PTSD compared to participants receiving TAU, at 6- and 12-months post trauma.

H3 Participants receiving CIPE+TAU will have significantly less symptoms of depression and insomnia than participants receiving TAU at 6 weeks post T1, and at 6-, and 12- months after the traumatic incident.

H4 Participants in the CIPE+TAU-condition will report significantly higher treatment satisfaction at post-treatment, compared to those in the TAU-condition.

H5 Participants with traumatic loss receiving CIPE+TAU will have significantly less symptoms of prolonged grief than such participants receiving TAU 12 months after the loss.

Cost-effectiveness H6 Fewer participants in the CIPE+TAU-condition will be referred to second-tier specialty mental health services, and more will achieve improved quality of life within the first year after the traumatic incident, compared to participants in the TAU-condition.

H7 The CIPE+TAU implementation is more cost-effective compared to the TAU in the short run and may even dominate TAU in the long run (i.e., more effective and less costly).

Being tested
Condensed internet-delivered prolonged exposure (CIPE), Treatment-as-usual (TAU)
Keywords
CIPE, PTSD, Indicated prevention, Prolonged Exposure
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Condensed internet-delivered prolonged exposure (CIPE)Behavioural

    'Condensed Internet-delivered Prolonged Exposure' (CIPE) is an intervention designed for victims with symptoms of post-traumatic stress disorder (PTSD) soon after a traumatic incident. CIPE is a therapist-supported intervention that consists of four modules delivered over the internet. Central CIPE-interventions include psychoeducation of normal post-traumatic reactions, in-vivo exposure, imaginary exposure, and a breathing exercise.

  • Treatment-as-usual (TAU)Behavioural

    There is currently considerable heterogeneity regarding the interventional principles applied in the Treatment-as-usual (TAU) condition across municipal crisis teams. The national guidelines (The Norwegian Directorate of Health, 2016), recommends several interventional principles such as psychological first aid (PFA), psychoeducation regarding crisis reactions/symptoms of acute stress, normalization of such reactions, activation of social support, and practical assistance.

Study groups in NCT06592677
Study groupRoleWhat they receive
Condensed internet-delivered prolonged exposure (CIPE) + Treatment-as-usual (TAU)ExperimentalParticipants in this condition will receive Treatment-as-usual (TAU) from psychosocial crisis teams throughout the entire participation period (1 year post trauma), in addition to CIPE as an add-on lasting for six weeks after randomization (T1; randomization from 4 to 7 weeks, dependent on when the participant is recruited). In CIPE, participants are encouraged to have daily contact with their therapist through a secured email system within the platform. Therapists are also available for phone sessions. Total therapist contact for each participant is generally less than 60 minutes during the whole program. Participants are expected to work on intervention tasks for six hours each week and to complete the intervention in three weeks. The intervention is delivered by psychosocial crisis teams' staff in 14 municipalities in the central-eastern part of Norway. Content, frequency, and quantity of the CIPE+TAU-condition will be measured.
Receives: Behavioral: Condensed internet-delivered prolonged exposure (CIPE); Behavioral: Treatment-as-usual (TAU)
Treatment-as-usual (TAU) onlyActive comparatorParticipants in this condition will receive Treatment-as-usual (TAU) throughout the entire participation period (1 year post trauma). The TAU-condition is delivered by the same municipality psychosocial crisis teams as the Condensed internet-delivered prolonged exposure (CIPE) +TAU arm. The crisis teams follow a national guideline (The Norwegian Directorate of Health, 2016), recommending proactive contact with victims, screening for psychosocial difficulties, and offering interventions to individuals with significant levels of trauma-related problems. Most municipalities organize interdisciplinary crisis services consisting of physicians, police, priests, nurses, and psychologists who receive referrals from emergency services after a traumatic event. There is currently considerable heterogeneity in the frequenzy and quantity of intervention across municipalities.
Receives: Behavioral: Treatment-as-usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PTSD Checklist for DSM-5 (PCL-5; Norwegian version)

    20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.

    Measured: Post-treatment (10 - 13 weeks after trauma)

Secondary outcomes (18)

  1. PTSD Checklist for DSM-5 (PCL-5; Norwegian version)

    20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.

    Measured: 6 months follow-up

  2. PTSD Checklist for DSM-5 (PCL-5; Norwegian version)

    20-item questionnaire that measures DSM-5-specified symptoms of post-traumatic stress disorder (PTSD). The total score ranges from 0 to 80, with higher scores indicating more severe symptoms. Items are rated on a 0 ("not at all") to 4 ("extremely") Likert type scale. The PCL-5 has demonstrated satisfactory psychometric properties in various trauma populations. This study will administer a Norwegian version of the PCL-5. Recall period: one month.

    Measured: 12 months follow-up

  3. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)

    30-item structured interview, developed to assess current and life-time post-traumatic stress disorder (PTSD)-diagnosis, as well as past-week PTSD symptoms. The instrument measures the 20 DSM-5 PTSD-symptoms, in addition to the onset and duration of symptoms, related subjective distress and functional impairment (social, occupational), amongst other aspects of the disorder. Standardized questions and probes are provided. A Norwegian version of the CAPS-5 are administered. CAPS-5 has demonstrated excellent psychometric properties.

    Measured: 6-months follow-up

  4. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Norwegian version)

    30-item structured interview, developed to assess current and life-time post-traumatic stress disorder (PTSD)-diagnosis, as well as past-week PTSD symptoms. The instrument measures the 20 DSM-5 PTSD-symptoms, in addition to the onset and duration of symptoms, related subjective distress and functional impairment (social, occupational), amongst other aspects of the disorder. Standardized questions and probes are provided. A Norwegian version of the CAPS-5 are administered. CAPS-5 has demonstrated excellent psychometric properties.

    Measured: 12-months follow-up

  5. Patient Health Questionnaire (PHQ-9; Norwegian version)

    9-item self-report measure of depressive symptom severity. The recall period is 2 weeks. Response is given on a 4-point Likert scale (0: not at all, 1: several days, 2: more than half the days, and 3: nearly every day), resulting in the total score ranging from 0 to 27. Higher scores indicate higher symptom severity. The instrument is sensitive for both clinical- and sub-clinical levels of depressive symptoms, and have demonstrated favorable psychometric properties. A validated Norwegian version of the PHQ-9 is applied.

    Measured: Post-treatment (10 - 13 weeks after trauma)

  6. Patient Health Questionnaire (PHQ-9; Norwegian version)

    9-item self-report measure of depressive symptom severity. The recall period is 2 weeks. Response is given on a 4-point Likert scale (0: not at all, 1: several days, 2: more than half the days, and 3: nearly every day), resulting in the total score ranging from 0 to 27. Higher scores indicate higher symptom severity. The instrument is sensitive for both clinical- and sub-clinical levels of depressive symptoms, and have demonstrated favorable psychometric properties. A validated Norwegian version of the PHQ-9 is applied.

    Measured: 6-months follow-up

  7. Patient Health Questionnaire (PHQ-9; Norwegian version)

    9-item self-report measure of depressive symptom severity. The recall period is 2 weeks. Response is given on a 4-point Likert scale (0: not at all, 1: several days, 2: more than half the days, and 3: nearly every day), resulting in the total score ranging from 0 to 27. Higher scores indicate higher symptom severity. The instrument is sensitive for both clinical- and sub-clinical levels of depressive symptoms, and have demonstrated favorable psychometric properties. A validated Norwegian version of the PHQ-9 is applied.

    Measured: 12-months follow-up

  8. Insomnia Severity Index (ISI; Norwegian version)

    7-item questionnaire, which measures insomnia symptoms during the past two weeks. The instrument utilizes a 5-point Likert scale ranging from 0 to 4, yielding a total score of 0-28. Higher scores indicate more insomnia symptoms. The ISI has demonstrated favorable psychometric properties. A Norwegian version of the ISI is applied.

    Measured: Post-treatment (10 - 13 weeks after trauma)

  9. Insomnia Severity Index (ISI; Norwegian version)

    7-item questionnaire, which measures insomnia symptoms during the past two weeks. The instrument utilizes a 5-point Likert scale ranging from 0 to 4, yielding a total score of 0-28. Higher scores indicate more insomnia symptoms. The ISI has demonstrated favorable psychometric properties. A Norwegian version of the ISI is applied.

    Measured: 6-months follow-up

  10. Insomnia Severity Index (ISI; Norwegian version)

    7-item questionnaire, which measures insomnia symptoms during the past two weeks. The instrument utilizes a 5-point Likert scale ranging from 0 to 4, yielding a total score of 0-28. Higher scores indicate more insomnia symptoms. The ISI has demonstrated favorable psychometric properties. A Norwegian version of the ISI is applied.

    Measured: 12-months follow-up

  11. Client Satisfaction Questionnaire (CSQ-8; Norwegian version)

    Eight-item measure of participants' service satisfaction. Response is given on a scale ranging from one to four, with a resulting total score range from eight to 32. Higher scores suggest higher service satisfaction. A validated Norwegian version of the CSQ-8 will be applied.

    Measured: Post-treatment (10 - 13 weeks after trauma)

  12. EQ-5D-5L (Norwegian version)

    Self-reported health-related quality of life. Self-care, mobility, pain/discomfort, usual activities, and anxiety/depression are measured on a 5-point scale. Response to each item is given by checking off one of five descriptions of functionality in that domain (e.g., have no problems doing my usual activities, slight problems, moderate problems, severe problems, or unable to do my usual activities). The total score ranges from 5 to 25, with higher scores indicating poorer health-related quality of life. Participant also rate their overall health on a scale from 1 (worst health) to 100 (best health). This scale is called the EQ VAS and is a part of the EQ-5D-5L. The instrument has demonstrated excellent psychometric properties. Recall period: today.

    Measured: Post-treatment (10 - 13 weeks after trauma)

  13. EQ-5D-5L (Norwegian version)

    Self-reported health-related quality of life. Self-care, mobility, pain/discomfort, usual activities, and anxiety/depression are measured on a 5-point scale. Response to each item is given by checking off one of five descriptions of functionality in that domain (e.g., have no problems doing my usual activities, slight problems, moderate problems, severe problems, or unable to do my usual activities). The total score ranges from 5 to 25, with higher scores indicating poorer health-related quality of life. Participant also rate their overall health on a scale from 1 (worst health) to 100 (best health). This scale is called the EQ VAS and is a part of the EQ-5D-5L. The instrument has demonstrated excellent psychometric properties. Recall period: today.

    Measured: 6-months follow-up

  14. EQ-5D-5L (Norwegian version)

    Self-reported health-related quality of life. Self-care, mobility, pain/discomfort, usual activities, and anxiety/depression are measured on a 5-point scale. Response to each item is given by checking off one of five descriptions of functionality in that domain (e.g., have no problems doing my usual activities, slight problems, moderate problems, severe problems, or unable to do my usual activities). The total score ranges from 5 to 25, with higher scores indicating poorer health-related quality of life. Participant also rate their overall health on a scale from 1 (worst health) to 100 (best health). This scale is called the EQ VAS and is a part of the EQ-5D-5L. The instrument has demonstrated excellent psychometric properties. Recall period: today.

    Measured: 12-months follow-up

  15. The Recovering Quality of Life (ReQoL; Norwegian version)

    Validated 10-item self-report measure of quality of life specific to people with different mental health conditions. The total score ranges from 0 to 40, with lower scores indicating low quality of life. The scale has demonstrated excellent psychometric properties.

    Measured: Post-treatment (10 - 13 weeks after trauma)

  16. The Recovering Quality of Life (ReQoL; Norwegian version)

    Validated 10-item self-report measure of quality of life specific to people with different mental health conditions. The total score ranges from 0 to 40, with lower scores indicating low quality of life. The scale has demonstrated excellent psychometric properties.

    Measured: 6-months follow-up

  17. The Recovering Quality of Life (ReQoL; Norwegian version)

    Validated 10-item self-report measure of quality of life specific to people with different mental health conditions. The total score ranges from 0 to 40, with lower scores indicating low quality of life. The scale has demonstrated excellent psychometric properties.

    Measured: 12-months follow-up

  18. Traumatic grief inventory self report, TGI-SR+

    The TGI-SR+ is a 22-item self-report questionnaire to assess symptoms of DSM-5 persistent complex bereavement disorder (PCBD), and ICD-11 Prolonged grief disorder (PGD). Total score ranges from 22 to 110, with higher scores indicating more severe symptoms. The instrument has demonstrated good psychometric properties. Recall period: last month.

    Measured: 12-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start13 Sep 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel two-armed multicenter add on randomized controlled trial.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06592677
Sponsor's protocol ID
302302
Acronym
EASE
Status last verified
Mar 2026
First submitted
29 Aug 2024
Last updated
23 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual participant outcome- and background data, and code generated from the project, will be made available upon reasonable request, to the degree permitted by ethical board approval.

Publications

  • Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.

    PubMed 26606250

  • Mekawi Y, Silverstein MW, Walker A, Ishiekwene M, Carter S, Michopoulos V, Stevens JS, Powers A. Examining the psychometric properties of the PCL-5 in a black community sample using item response theory. J Anxiety Disord. 2022 Apr;87:102555. doi: 10.1016/j.janxdis.2022.102555. Epub 2022 Mar 10.

    PubMed 35338915

  • Sveen J, Bondjers K, Willebrand M. Psychometric properties of the PTSD Checklist for DSM-5: a pilot study. Eur J Psychotraumatol. 2016 Apr 19;7:30165. doi: 10.3402/ejpt.v7.30165. eCollection 2016.

    PubMed 27098450

  • Marx BP, Lee DJ, Norman SB, Bovin MJ, Sloan DM, Weathers FW, Keane TM, Schnurr PP. Reliable and clinically significant change in the clinician-administered PTSD Scale for DSM-5 and PTSD Checklist for DSM-5 among male veterans. Psychol Assess. 2022 Feb;34(2):197-203. doi: 10.1037/pas0001098. Epub 2021 Dec 23.

    PubMed 34941354

  • Weathers FW, Bovin MJ, Lee DJ, Sloan DM, Schnurr PP, Kaloupek DG, Keane TM, Marx BP. The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5): Development and initial psychometric evaluation in military veterans. Psychol Assess. 2018 Mar;30(3):383-395. doi: 10.1037/pas0000486. Epub 2017 May 11.

    PubMed 28493729

  • Brattmyr M, Lindberg MS, Solem S, Hjemdal O, Havnen A. Factor structure, measurement invariance, and concurrent validity of the Patient Health Questionnaire-9 and the Generalized Anxiety Disorder scale-7 in a Norwegian psychiatric outpatient sample. BMC Psychiatry. 2022 Jul 11;22(1):461. doi: 10.1186/s12888-022-04101-z.

    PubMed 35818021

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PubMed 11556941

  • Wisting L, Johnson SU, Bulik CM, Andreassen OA, Ro O, Bang L. Psychometric properties of the Norwegian version of the Patient Health Questionnaire-9 (PHQ-9) in a large female sample of adults with and without eating disorders. BMC Psychiatry. 2021 Jan 5;21(1):6. doi: 10.1186/s12888-020-03013-0.

    PubMed 33402149

  • Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.

    PubMed 11438246

  • Buysse DJ, Ancoli-Israel S, Edinger JD, Lichstein KL, Morin CM. Recommendations for a standard research assessment of insomnia. Sleep. 2006 Sep;29(9):1155-73. doi: 10.1093/sleep/29.9.1155.

    PubMed 17040003

  • Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.

    PubMed 21532953

  • Pedersen H, Havnen A, Brattmyr M, Attkisson CC, Lara-Cabrera ML. A digital Norwegian version of the client satisfaction questionnaire 8: factor validity and internal reliability in outpatient mental health care. BMC Psychiatry. 2022 Oct 31;22(1):671. doi: 10.1186/s12888-022-04281-8.

    PubMed 36316661

  • Feng YS, Kohlmann T, Janssen MF, Buchholz I. Psychometric properties of the EQ-5D-5L: a systematic review of the literature. Qual Life Res. 2021 Mar;30(3):647-673. doi: 10.1007/s11136-020-02688-y. Epub 2020 Dec 7.

    PubMed 33284428

  • Keetharuth AD, Brazier J, Connell J, Bjorner JB, Carlton J, Taylor Buck E, Ricketts T, McKendrick K, Browne J, Croudace T, Barkham M. Recovering Quality of Life (ReQoL): a new generic self-reported outcome measure for use with people experiencing mental health difficulties. Br J Psychiatry. 2018 Jan;212(1):42-49. doi: 10.1192/bjp.2017.10.

    PubMed 29433611

  • Lenferink LIM, Eisma MC, Smid GE, de Keijser J, Boelen PA. Valid measurement of DSM-5 persistent complex bereavement disorder and DSM-5-TR and ICD-11 prolonged grief disorder: The Traumatic Grief Inventory-Self Report Plus (TGI-SR+). Compr Psychiatry. 2022 Jan;112:152281. doi: 10.1016/j.comppsych.2021.152281. Epub 2021 Oct 21.

    PubMed 34700189

Questions about this trial

What is this clinical trial studying?

A study testing Condensed internet-delivered prolonged exposure (CIPE) and Treatment-as-usual (TAU) in people with Post-traumatic Stress Disorder, run by Norwegian Center for Violence and Traumatic Stress Studies at 29 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Harald Bækkelund, PhD (+47 90964268, harald.bakkelund@nkvts.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PTSD Checklist for DSM-5 (PCL-5; Norwegian version) (time frame: Post-treatment (10 - 13 weeks after trauma)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06592677, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.

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